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Sponsors and Collaborators: |
Medical College of Wisconsin National Center for Research Resources (NCRR) |
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Information provided by: | Medical College of Wisconsin |
ClinicalTrials.gov Identifier: | NCT00312078 |
The purpose of this study is to determine whether a special yogurt can improve performance on certain tests of intelligence and decrease liver inflammation in patients with cirrhosis.
Condition | Intervention |
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Cirrhosis Minimal Hepatic Encephalopathy |
Dietary Supplement: Yogurt Supplementation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Yogurt Supplementation on Psychometric Test Performance in Cirrhotic Patients With Minimal Hepatic Encephalopathy. A Prospective Pilot Trial. |
Estimated Enrollment: | 30 |
Study Start Date: | November 2005 |
Study Completion Date: | April 2007 |
Introduction: Cirrhosis is one of the leading causes of death in the United States. Minimal hepatic encephalopathy (MHE) is a significant complication of cirrhosis, which is often not treated because of perceived subclinical nature of this condition and the adverse effects and expense of available medications such as lactulose or rifaximin. There is evidence that small intestinal bacterial overgrowth can contribute to the development of MHE and cirrhosis in murine and human studies. Probiotics are live bacteria that can modify the indigenous intestinal bacterial flora and have been recently used in the treatment of hepatic encephalopathy in patients with cirrhosis. Our aim is to evaluate the effect of probiotic supplementation via yogurt on liver function and inflammatory markers of bacterial translocation and psychometric test performance in cirrhotic patients with MHE in a prospective pilot trial.
Methods: 30 patients with MHE 2:1 i.e. 20 will be randomized into supplementation with yogurt to be taken 6 ounces twice a day for 60 days and 10 patients will be followed up without yogurt supplementation. All patients will undergo liver function tests, basic metabolic panel, INR, venous ammonia, IL-6 and TNF-alpha at baseline, 30 days and at 60 days. All patients will also undergo psychometric testing with number connection test A, digit symbol test, block design and inhibitory control test at baseline and 60 days. Regular questioning about adherence to yogurt. Collection of yogurt tops as proof of yogurt consumption and review of intake diary will be done at 30 and 60 days from patients randomized to yogurt supplementation.
Importance: There has been only one human study on the modification of gut flora as a therapeutic tool for improvement of MHE in cirrhosis, however that study included alcoholic liver disease and comprised of Chinese patients, therefore etiologies of liver diseases studied were different from those predominant in the United States. Since MHE can adversely affect quality of life and overall prognosis, simple, targeted therapies are needed to treat it. We believe that our pilot study will help delineate human gut flora as a definite target for therapy of cirrhosis and MHE and pave the way for future large-scale studies on this subject.
Ages Eligible for Study: | 24 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
United States, Wisconsin | |
GCRC Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Principal Investigator: | Jasmohan S Bajaj, MD | Medical College of Wisconsin |
Study ID Numbers: | GCRC protocol 810; HRRC 360-05 |
Study First Received: | April 5, 2006 |
Last Updated: | October 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00312078 History of Changes |
Health Authority: | United States: Institutional Review Board |
Minimal Hepatic Encephalopathy Cirrhosis |
Liver Diseases Neurotoxicity Syndromes Fibrosis Brain Damage, Chronic Disorders of Environmental Origin Liver Cirrhosis Brain Diseases Signs and Symptoms Mental Disorders Brain Injuries Dementia Metabolic Disorder Neurobehavioral Manifestations Hepatic Insufficiency Delirium |
Liver Failure Metabolic Diseases Poisoning Central Nervous System Diseases Confusion Encephalitis Cognition Disorders Virus Diseases Hepatic Encephalopathy Digestive System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Central Nervous System Infections Neurologic Manifestations Brain Diseases, Metabolic |
Liver Diseases Neurotoxicity Syndromes Fibrosis Brain Damage, Chronic Disorders of Environmental Origin Central Nervous System Viral Diseases Liver Cirrhosis Brain Diseases Signs and Symptoms Pathologic Processes Mental Disorders Neurobehavioral Manifestations Hepatic Insufficiency Delirium |
Liver Failure Metabolic Diseases Nervous System Diseases Poisoning Central Nervous System Diseases Confusion Encephalitis Virus Diseases Hepatic Encephalopathy Digestive System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Central Nervous System Infections Neurologic Manifestations Brain Diseases, Metabolic |